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###### Department of Health and Human Services

###### National Institutes of Health

# AGENCY:

National Institutes of Health, HHS.

# ACTION:

Notice.

# SUMMARY:

The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

# FOR FURTHER INFORMATION CONTACT:

                        Licensing information may be obtained by communicating with the Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases, 5601 Fishers Lane, Rockville, MD 20852 by contacting Dawn Taylor-Mulneix at 301-451-8021 or                         *dawn.taylor-mulneix@nih.gov.*                         A signed Confidential Disclosure Agreement will be required to receive copies of unpublished information related to the invention.                    

# SUPPLEMENTARY INFORMATION:

Technology description follows:

## Equipping Natural Killer Cells With a CD28H-Containing Chimeric Antigen Receptor To Overcome Inhibition for Cancer Immunotherapy

### Description of Technology

                    Immunotherapy with chimeric antigen receptor (CAR) cytotoxic T cells have been successful in the clinical treatment of hematologic cancers; however adverse side effects such as severe cytokine release syndrome and neurotoxicity are associated with CAR-T cell infusion. CAR natural killer (NK) cells represent a viable alternative with demonstrated advantages over CAR-T cells for the elimination of tumor cells, but NK inhibitory cell receptors need to be reduced or overridden. To overcome this challenge, scientists at NIAID have developed CAR constructs that overcome inhibition of NK cells by receptors for human major histocompatibility complex molecules HLA-E and HLA-C, based on in vitro studies. NK cells that are expressing variants of this invention robustly overcome inhibition imposed by CD19+                     HLA-I+                     tumor cells and are cytotoxic to them.                

This technology is available for licensing for commercial development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as well as for further development and evaluation under a research collaboration.

### Potential Commercial Applications

    - Method of adoptive cell therapy where CAR-NK cells are the effective cell.

### Competitive Advantages

    - CD28H CAR-NK cells induce a more robust anti-tumor cytotoxic activity compared to third generation CAR-T cells and are more potent in overcoming inhibition.
    - CAR-NK can be developed without the need of genetic silencing of TCR.

### Developmental Stage

    - Pre-clinical.

*Inventors:*                     Eric Long, Ph.D. and Xiaoxuan Zhuang, both of NIAID.                

*Publications:*

                    Zhuang X., Long E.O., “NK cells equipped with a chimeric antigen receptor that overcomes inhibition by HLA Class I for adoptive transfer of CAR-NK Cells. Front. Immunol. 13:840844.                     *https://www.frontiersin.org/​articles/​10.3389/​fimmu.2022.840844/​full.*                     May 2, 2022.                

                    Zhuang X. and Long E.O., “CD28 homolog is a strong activator of Natural Killer cells for lysis of B7H7-positive tumor cells.” Cancer Immunol. Res. 7(6):939-951.                     *https://cancerimmunolres.aacrjournals.org/​content/​7/​6/​939.long.*                     April 24, 2019.                

                    Zhuang X, Long E.O. “Inhibition-resistant CARs for NK cell cancer immunotherapy.” Trends Immunol. 40(12):1078-1081.                    *https://www.sciencedirect.com/​science/​article/​pii/​S1471490619302133?​via%3Dihub.*                     November 12, 2019.                

*Intellectual Property:*                     HHS Reference No. E-097-2020; Patent Application Nos.: PCT Application No. PCT/US2020/02498, US: 17/914,027, Australia: 2020437669, Brazil: BR112022017512-4, Canada: 3174779, Europe: 20719313.7, India: 2022170585054, Japan: 2022-557764, South Korea: 10-2022-7037236.                

*Licensing Contact:*                     To license this technology, please contact Dawn Taylor-Mulneix at 301-451-8021 or                     *dawn.taylor-mulneix@nih.gov,*                     and reference E-097-2020.                

*Collaborative Research Opportunity:*                     The National Institute of Allergy and Infectious Diseases is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this technology. For collaboration opportunities, please contact Dawn Taylor-Mulneix at 301-451-8021 or                     *dawn.taylor-mulneix@nih.gov.*

Dated: February 9, 2024.

Surekha Vathyam,

Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases.

[FR Doc. 2024-03121 Filed 2-14-24; 8:45 am]

BILLING CODE 4140-01-P